Guide to application of the ATEX 2014/34/UE directive - ANNEX VII MODULE E: CONFORMITY TO TYPE BASED ON PRODUCT QUALITY ASSURANCE

ANNEX VII

MODULE E: CONFORMITY TO TYPE BASED ON PRODUCT QUALITY ASSURANCE

1.           Conformity to type based on product quality assurance is that part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the products concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to them.

§ 208  Conformity to type based on product quality assurance

Module E “Conformity to type based on product quality assurance” as Annex VII to the ATEX Directive 2014/34/EU (indicated as “Product quality assurance” in the previous Directive 94/9/EC) is one of modules that may be applied after the Module B (EU-type examination certificate, Annex III).

This conformity assessment procedure is based on a quality system approved by a notified body for the final inspection and testing of equipment subject to on-going surveillance.

2.           Manufacturing

              The manufacturer shall operate an approved quality system for final product inspection and testing of the products concerned as specified in point 3 and shall be subject to surveillance as specified in point 4.

§ 209  Manufacturing

The manufacturer has to implement and manage an approved quality system for final product inspection and testing of his products, in order to ensure compliance of the manufactured products to the approved EU-type (under module B) and the legislative requirements.

For the general obligations of manufacturers, see section § 75.

3.           Quality system

3.1.        The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the products concerned.

              The application shall include:

              (a)     the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well,

              (b)     a written declaration that the same application has not been lodged with any other notified body,

              (c)     all relevant information for the product category envisaged,

              (d)     the documentation concerning the quality system, and

              (e)     the technical documentation of the approved type and a copy of the EU-type examination certificate.

3.2.        The quality system shall ensure compliance of the products with the type described in the EU-type examination certificate and with the applicable requirements of this Directive.

              All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.

              It shall, in particular, contain an adequate description of:

              (a)     the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality,

              (b)     the examinations and tests that will be carried out after manufacture,

              (c)     the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.,

              (d)     the means of monitoring the effective operation of the quality system.

3.3.        The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2.

              It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard.

              In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant product field and product technology concerned, and knowledge of the applicable requirements of this Directive. The audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation referred to in point 3.1(e) in order to verify the manufacturer's ability to identify the relevant requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements.

              The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

3.4.        The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

3.5.        The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

              The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.

              It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

§ 210  Quality system

The quality system must include the following elements, to be documented:

- quality objectives,

- organisational structure,

- tests (carried out after the manufacturing),

- quality records, and

- monitoring methods.

Tests carried out before or during the manufacturing, as well as manufacturing techniques, are not part of the quality system under module E (as it is the case for modules D), because module E targets the final product quality and not the quality of the whole production process (as it is the case for module D).

4.           Surveillance under the responsibility of the notified body

4.1.        The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

4.2.        The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:

              (a)     the quality system documentation,

              (b)     the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.

4.3.        The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.

4.4.        In addition, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

§ 211  Surveillance under the responsibility of the notified body

The notified body performs periodic audits in order to assess and survey the quality system. Audits include:

- control of the quality system,

- inspections, and

- product tests.

The notified body takes into account the technical documentation but does not examine it, as it has been already examined under module B.

5.           CE marking, EU declaration of conformity and attestation of conformity

5.1.        The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 3.1, the latter's identification number to each individual product other than a component that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Directive.

5.2.        The manufacturer shall draw up a written EU declaration of conformity for each product model, other than a component and keep it at the disposal of the national authorities for 10 years after the product other than a component has been placed on the market. The EU declaration of conformity shall identify such product model for which it has been drawn up.

              A copy of the EU declaration of conformity shall accompany every product other than a component.

5.3.        The manufacturer shall draw up a written attestation of conformity for each component model and keep it at the disposal of the national authorities for 10 years after the component has been placed on the market. The attestation of conformity shall identify the component model for which it has been drawn up. A copy of the attestation of conformity shall accompany every component.

§ 212  CE marking, EU declaration of conformity and attestation of conformity

As in this conformity assessment module (E) the notified body is involved in the production phase, the CE marking must be followed by the identification number of the notified body.

CE marking should not be affixed to a component, but only the identification number of the notified body involved in the production phase.

A written declaration of conformity should be issued by the manufacturer (or its authorised representative) except for components. For components a written attestation of conformity must be issued.

6.           The manufacturer shall, for a period ending 10 years after the product has been placed on the market, keep at the disposal of the national authorities:

              (a)     the documentation referred to in point 3.1,

              (b)     the information relating to the change referred to in point 3.5, as approved,

              (c)     the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4.

§ 213  Obligations for the manufacturer

The provision on "10 years after the product has been placed on the market" should be understood as related to the last item of the product model placed on the market.

7.           Each notified body shall inform its notifying authority of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of quality system approvals refused, suspended or otherwise restricted.

              Each notified body shall inform the other notified bodies of quality system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued.

§ 214  Obligations for the notified body

Notified bodies are obliged to co-operation and coordination of its activity. In particular, notified bodies have a general obligation to inform national market surveillance authorities and the other notified bodies about the assessments of quality systems they have carried out.

8.           Authorised representative

              The manufacturer's obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.

§ 215  Authorised representative

According to the mandate contractually agreed with the manufacturer, the authorised representative can be entitled to lodge the application for the assessment of the quality system and to fulfil the obligations related to information, marking, declaration or attestation of conformity, and to retaining the relevant documentation.

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